Back to resultsAnastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function (CAP)
Primary Purpose
Hypogonadism, Male
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Anastrozole 1mg
Clomiphene Citrate 25mg
Placebo - Cap
Sponsored by
About this trial
This is an interventional treatment trial for Hypogonadism, Male
Eligibility Criteria
Inclusion Criteria:
- Men age 18-70
- Baseline morning Testosterone 150-350 ng/dL x2
- leutenizing hormone (LH) 1.5-9.2 miU/mL, Follicle stimulation hormone (FSH) 1.6-8.0 miU/mL, Prolactin 4-15 ng/mL
- Positive Androgen Deficiency in the Aging Male (ADAM) score. A positive score is when an affirmative answer (''yes'') to either questions "Do you have a decreased sex drive/libido?" or "Are your erections less strong?" or any three other questions.10
- Body mass index (BMI) <40
- Sexual health inventory for men (SHIM) score >7 and <21. Patients are allowed to be taking phosphodiesterase 5 inhibitors (i.e. Viagra, Levitra, Cialis) at baseline, however we will ask them to do the SHIM survey as if they were not taking this medication.
- Men must attempt to have at least four sexual encounters over each of the eight-week periods
- Men willing not to take phosphodiesterase 5 inhibitors throughout the entire study
Exclusion Criteria:
- Current or previous history of prostate cancer
- Previous or current androgen deprivation therapy for prostate cancer,
- Past surgical history of prostatectomy.
- History of testicular cancer.
- History of deep vein thrombosis (DVT) or blood dyscrasia
- History of breast cancer
- Men with past or current treatment for erectile dysfunction including MUSE (alprostodil), intracavernosal injections, penile prosthesis. Men not on treatment or men who are on phosphodiesterase inhibitors will be allowed to be in the study but must stop their use at the screening visit.
- Chronic opioid use
- Use of steroids within the past 3 months, including prednisone and/or cortisone injections, and inhaled steroids. Topical steroid cream is acceptable.
- History of or current use of anabolic steroids, i.e. testosterone, (or any analog of testosterone) dihydroepiandrosterone (DHEA), dihydroepiandrosterone sulfate (DHEAS) or any growth promoters i.e. growth hormone itself or analogs of growth hormone
- History of or current use of anti-androgen medications, i.e. Aldactone, Tagamet, estrogens
- Alcohol intake > 30 grams (drink more than 2 beers per day OR more than 1 glass of wine or cocktail daily)
- Having started a new medication during the past three months which may interfere with the outcome measures of the study
- Polycythemia (HCT >52% )
- History of prostate specific antigen (PSA)> 4.0 ng/dl
- Hematocrit (HCT)< 36 %
- Liver function tests greater than 2 times upper normal limits or history of abnormal electrolytes, calcium or Parathyroid hormone without workup, at the discretion of the investigator.
- Previous hypogonadal treatment within last 3 months. -
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Other
Other
Other
Other
Other
Other
Arm Label
anastrazole-clomiphene-placebo
anastrazole-placebo-clomiphene
clomiphene-anastrazole-placebo
clomiphene-placebo-anastrazole
placebo-clomiphene-anastrazole
placebo-anastrazole-clomiphene
Arm Description
anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks
anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks
clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks
clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks
placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks
placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks
Outcomes
Primary Outcome Measures
IIEF (International Index of Erectile Function) Score - Screen
15 item self reported erectile function. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
IIEF (International Index of Erectile Function) Score - Week 8
15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
IIEF (International Index of Erectile Function) Score - Week 16
15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
IIEF (International Index of Erectile Function) Score - Week 24
15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
Secondary Outcome Measures
Normalized Testosterone - Screen
Normalized at >350ng/dl
Normalized Testosterone - Week 8
Normalized at >350ng/dl
Normalized Testosterone - Week 16
Normalized at >350ng/dl
Normalized Testosterone - Week 24
Normalized at >350ng/dl
ADAM (Androgen Deficiency in the Aging Male) Score - Screen
Self reported quantification of hypogonadism. 10 "yes" or "no" questions.
A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions.
Yes (1) represents a better outcome than No (1)
In Data Entry:
Yes - 1 No - 0
ADAM (Androgen Deficiency in the Aging Male) Score - Week 8
Self reported quantification of hypogonadism. 10 "yes" or "no" questions.
A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions.
Yes (1) represents a better outcome than No (1)
In Data Entry:
Yes - 1 No - 0
ADAM (Androgen Deficiency in the Aging Male) Score - Week 16
Self reported quantification of hypogonadism. 10 "yes" or "no" questions.
A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions.
Yes (1) represents a better outcome than No (1)
In Data Entry:
Yes - 1 No - 0
ADAM (Androgen Deficiency in the Aging Male) Score - Week 24
Self reported quantification of hypogonadism. 10 "yes" or "no" questions.
A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions.
Yes (1) represents a better outcome than No (1)
In Data Entry:
Yes - 1 No - 0
EHS (Erectile Hardness Score) - Screen
Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid
EHS (Erectile Hardness Score) - Week 8
Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid
EHS (Erectile Hardness Score) - Week 16
Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid
EHS (Erectile Hardness Score) - Week 24
Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid
LH - Screen
Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.
LH - Week 8
Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.
LH - Week 16
Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.
LH - Week 24
Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.
FSH - Screen
Lab Values for follicle stimulating hormone
FSH - Week 8
Lab Values for follicle stimulating hormone
FSH - Week 16
Lab Values for follicle stimulating hormone
FSH - Week 24
Lab Values for follicle stimulating hormone
Free Testosterone - Screen
Measure of Free Testosterone
Free Testosterone - Week 8
Measure of Free Testosterone
Free Testosterone - Week 16
Measure of Free Testosterone
Free Testosterone - Week 24
Measure of Free Testosterone
Estradiol - Screen
Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24
Estradiol - Week 8
Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5
Estradiol - Week 16
Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5
Estradiol - Week 24
Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5
SHBG - Screen
Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24
SHBG - Week 8
Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24
SHBG - Week 16
Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24
SHBG - Week 24
Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24
SEP #1-3 Cumulative - Screen
Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3.
0-3: cumulative score from SEP questions 1, 2, and 3
Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0
SEP #1-3 Cumulative - Week 8
Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3.
0-3: cumulative score from SEP questions 1, 2, and 3
Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0
SEP #1-3 Cumulative - Week 16
Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3.
0-3: cumulative score from SEP questions 1, 2, and 3
Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0
SEP #1-3 Cumulative - Week 24
Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3.
0-3: cumulative score from SEP questions 1, 2, and 3
Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0
Full Information
NCT ID
NCT03933618
First Posted
April 29, 2019
Last Updated
October 26, 2019
Sponsor
Albany Medical College
Collaborators
Laboratory Corporation of America
1. Study Identification
Unique Protocol Identification Number
NCT03933618
Brief Title
Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function
Acronym
CAP
Official Title
A Randomized Double Blinded Placebo Controlled Trial Between Anastrozole and Clomiphene to Evaluate Improvement in Hypogonadal Symptoms and Erectile Function Using ADAM, IIEF and EHS Validated Scales
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 2, 2015 (Actual)
Primary Completion Date
March 8, 2017 (Actual)
Study Completion Date
March 8, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albany Medical College
Collaborators
Laboratory Corporation of America
4. Oversight
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates anastrazole and clomiphene in the improvement in hypogonadal symptoms and erectile function. Each subject will receive Anastrazole 1 mg/day, clomiphene 25 mg/day and placebo in randomized schedule of 8 week intervals.
Detailed Description
Aromatase inhibitors (AI) (Anastrazole) and selective estrogen receptor modifiers (SERMS)(clomiphene) increase testosterone production through stimulation of the hypothalamic pituitary axis. While these drugs both reduce the feedback inhibition of estrogen on the pituitary, SERMs cause an increase in serum estradiol, whereas AIs reduce estradiol levels. Using these medications, we can obtain therapeutic testosterone levels with either an increase or decrease in estradiol levels.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism, Male
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
anastrazole-clomiphene-placebo
Arm Type
Other
Arm Description
anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks
Arm Title
anastrazole-placebo-clomiphene
Arm Type
Other
Arm Description
anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks
Arm Title
clomiphene-anastrazole-placebo
Arm Type
Other
Arm Description
clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks
Arm Title
clomiphene-placebo-anastrazole
Arm Type
Other
Arm Description
clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks
Arm Title
placebo-clomiphene-anastrazole
Arm Type
Other
Arm Description
placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks
Arm Title
placebo-anastrazole-clomiphene
Arm Type
Other
Arm Description
placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks
Intervention Type
Drug
Intervention Name(s)
Anastrozole 1mg
Intervention Type
Drug
Intervention Name(s)
Clomiphene Citrate 25mg
Intervention Type
Drug
Intervention Name(s)
Placebo - Cap
Primary Outcome Measure Information:
Title
IIEF (International Index of Erectile Function) Score - Screen
Description
15 item self reported erectile function. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
Time Frame
At baseline
Title
IIEF (International Index of Erectile Function) Score - Week 8
Description
15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
Time Frame
Week 8
Title
IIEF (International Index of Erectile Function) Score - Week 16
Description
15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
Time Frame
Week 16
Title
IIEF (International Index of Erectile Function) Score - Week 24
Description
15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Normalized Testosterone - Screen
Description
Normalized at >350ng/dl
Time Frame
Baseline
Title
Normalized Testosterone - Week 8
Description
Normalized at >350ng/dl
Time Frame
Week 8
Title
Normalized Testosterone - Week 16
Description
Normalized at >350ng/dl
Time Frame
Week 16
Title
Normalized Testosterone - Week 24
Description
Normalized at >350ng/dl
Time Frame
Week 24
Title
ADAM (Androgen Deficiency in the Aging Male) Score - Screen
Description
Self reported quantification of hypogonadism. 10 "yes" or "no" questions.
A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions.
Yes (1) represents a better outcome than No (1)
In Data Entry:
Yes - 1 No - 0
Time Frame
Baseline
Title
ADAM (Androgen Deficiency in the Aging Male) Score - Week 8
Description
Self reported quantification of hypogonadism. 10 "yes" or "no" questions.
A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions.
Yes (1) represents a better outcome than No (1)
In Data Entry:
Yes - 1 No - 0
Time Frame
Week 8
Title
ADAM (Androgen Deficiency in the Aging Male) Score - Week 16
Description
Self reported quantification of hypogonadism. 10 "yes" or "no" questions.
A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions.
Yes (1) represents a better outcome than No (1)
In Data Entry:
Yes - 1 No - 0
Time Frame
Week 16
Title
ADAM (Androgen Deficiency in the Aging Male) Score - Week 24
Description
Self reported quantification of hypogonadism. 10 "yes" or "no" questions.
A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions.
Yes (1) represents a better outcome than No (1)
In Data Entry:
Yes - 1 No - 0
Time Frame
Week 24
Title
EHS (Erectile Hardness Score) - Screen
Description
Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid
Time Frame
Baseline
Title
EHS (Erectile Hardness Score) - Week 8
Description
Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid
Time Frame
Week 8
Title
EHS (Erectile Hardness Score) - Week 16
Description
Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid
Time Frame
Week 16
Title
EHS (Erectile Hardness Score) - Week 24
Description
Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid
Time Frame
Week 24
Title
LH - Screen
Description
Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.
Time Frame
Baseline
Title
LH - Week 8
Description
Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.
Time Frame
Week 8
Title
LH - Week 16
Description
Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.
Time Frame
Week 16
Title
LH - Week 24
Description
Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.
Time Frame
Week 24
Title
FSH - Screen
Description
Lab Values for follicle stimulating hormone
Time Frame
Baseline
Title
FSH - Week 8
Description
Lab Values for follicle stimulating hormone
Time Frame
Week 8
Title
FSH - Week 16
Description
Lab Values for follicle stimulating hormone
Time Frame
Week 16
Title
FSH - Week 24
Description
Lab Values for follicle stimulating hormone
Time Frame
Week 24
Title
Free Testosterone - Screen
Description
Measure of Free Testosterone
Time Frame
Baseline
Title
Free Testosterone - Week 8
Description
Measure of Free Testosterone
Time Frame
Week 8
Title
Free Testosterone - Week 16
Description
Measure of Free Testosterone
Time Frame
Week 16
Title
Free Testosterone - Week 24
Description
Measure of Free Testosterone
Time Frame
Week 24
Title
Estradiol - Screen
Description
Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24
Time Frame
Baseline
Title
Estradiol - Week 8
Description
Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5
Time Frame
Week 8
Title
Estradiol - Week 16
Description
Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5
Time Frame
Week 16
Title
Estradiol - Week 24
Description
Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5
Time Frame
Week 24
Title
SHBG - Screen
Description
Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24
Time Frame
Baseline
Title
SHBG - Week 8
Description
Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24
Time Frame
Week 8
Title
SHBG - Week 16
Description
Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24
Time Frame
Week 16
Title
SHBG - Week 24
Description
Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24
Time Frame
Week 24
Title
SEP #1-3 Cumulative - Screen
Description
Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3.
0-3: cumulative score from SEP questions 1, 2, and 3
Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0
Time Frame
Baseline
Title
SEP #1-3 Cumulative - Week 8
Description
Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3.
0-3: cumulative score from SEP questions 1, 2, and 3
Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0
Time Frame
Week 8
Title
SEP #1-3 Cumulative - Week 16
Description
Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3.
0-3: cumulative score from SEP questions 1, 2, and 3
Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0
Time Frame
Week 16
Title
SEP #1-3 Cumulative - Week 24
Description
Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3.
0-3: cumulative score from SEP questions 1, 2, and 3
Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0
Time Frame
Week 24
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men age 18-70
Baseline morning Testosterone 150-350 ng/dL x2
leutenizing hormone (LH) 1.5-9.2 miU/mL, Follicle stimulation hormone (FSH) 1.6-8.0 miU/mL, Prolactin 4-15 ng/mL
Positive Androgen Deficiency in the Aging Male (ADAM) score. A positive score is when an affirmative answer (''yes'') to either questions "Do you have a decreased sex drive/libido?" or "Are your erections less strong?" or any three other questions.10
Body mass index (BMI) <40
Sexual health inventory for men (SHIM) score >7 and <21. Patients are allowed to be taking phosphodiesterase 5 inhibitors (i.e. Viagra, Levitra, Cialis) at baseline, however we will ask them to do the SHIM survey as if they were not taking this medication.
Men must attempt to have at least four sexual encounters over each of the eight-week periods
Men willing not to take phosphodiesterase 5 inhibitors throughout the entire study
Exclusion Criteria:
Current or previous history of prostate cancer
Previous or current androgen deprivation therapy for prostate cancer,
Past surgical history of prostatectomy.
History of testicular cancer.
History of deep vein thrombosis (DVT) or blood dyscrasia
History of breast cancer
Men with past or current treatment for erectile dysfunction including MUSE (alprostodil), intracavernosal injections, penile prosthesis. Men not on treatment or men who are on phosphodiesterase inhibitors will be allowed to be in the study but must stop their use at the screening visit.
Chronic opioid use
Use of steroids within the past 3 months, including prednisone and/or cortisone injections, and inhaled steroids. Topical steroid cream is acceptable.
History of or current use of anabolic steroids, i.e. testosterone, (or any analog of testosterone) dihydroepiandrosterone (DHEA), dihydroepiandrosterone sulfate (DHEAS) or any growth promoters i.e. growth hormone itself or analogs of growth hormone
History of or current use of anti-androgen medications, i.e. Aldactone, Tagamet, estrogens
Alcohol intake > 30 grams (drink more than 2 beers per day OR more than 1 glass of wine or cocktail daily)
Having started a new medication during the past three months which may interfere with the outcome measures of the study
Polycythemia (HCT >52% )
History of prostate specific antigen (PSA)> 4.0 ng/dl
Hematocrit (HCT)< 36 %
Liver function tests greater than 2 times upper normal limits or history of abnormal electrolytes, calcium or Parathyroid hormone without workup, at the discretion of the investigator.
Previous hypogonadal treatment within last 3 months. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert C Welliver, MD
Organizational Affiliation
Albany Medical College
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function
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